Laboratory Specialist, Quality Assurance - PM Shift

JenaValve is a global medical device company focused on developing and manufacturing innovative Transcatheter Aortic Valve Replacement (TAVR) systems for the treatment of patients with severe aortic regurgitation and aortic stenosis.

Our mission is to raise awareness of aortic regurgitation and transform treatment options for patients living with this condition.

Our Leeds manufacturing facility produces the proprietary porcine pericardial tissue valves used within the JenaValve TAVR System.

Joining JenaValve means becoming part of a team that is dedicated to delivering high-quality medical devices and supporting advancements in patient care across the world.

We are looking to recruit three Laboratory Specialists to provide quality assurance support to the Leeds Laboratories (chemistry and microbiology).

The role will involve supporting the QA team to ensures site is compliant with company and regulatory requirements for:

• Biocontamination control / monitoring program per ISO 14698, other relevant standards, and internal procedure.
• Manufactured solution analysis / release for production use.
• Laboratory method development, qualification, transfer, and analyst training / certification.
• Laboratory equipment calibration, maintenance, and qualification.
• Conduct of solution shelf life/stability studies (including protocol, report development).
• TLS sterilization activities and annual review/ revalidation(s). 
• Packaging component sterilization (steam and gamma irradiation) and process oversight
• Contract laboratory finished product endotoxin and testing.
• Data governance/review and data integrity requirements (good documentation practice).
• Identifying and supporting continuous improvement initiatives in laboratory documentation and practices.
• Providing ongoing visibility of laboratory activities, deviations, and projects to supervisor/QA team. 

Supports site Operations and Quality Assurance in executing laboratory workloads per assigned priority while assuring compliance with applicable procedures, standards, and regulatory requirements, encompassing:

• Routine solution analysis (chemical, microbiological) and release to production.
• Ongoing environmental monitoring and controlled environment certification(s).
• Training other Leeds personnel involved in laboratory testing.
• Ensuring data is documented per procedures and regulatory requirements and is reported to supervisor/Quality management in a timely manner. Supporting development of monthly trend analyses as required.
• Supporting preparation of protocols, protocol execution, and report preparation for validations; assures compliance with the site Validation Master Plan.
• Supporting continuous improvement initiatives for efficiency and productivity in relation to lab practices, site biocontamination control program, work instructions/forms, and site support activities.
• Providing technical support/ troubleshooting in the event of lab equipment failure, deviations or out of specification results. Participates in and documents root cause analysis investigations and assists in the development and implementation of corrective and/or preventive actions.
• Supporting site Health and Safety program (COSHH) and assists in Risk Assessments as assigned.
• Represents Chemistry and/or Microbiology laboratories on cross-functional teams as assigned.
• Ensuring company and regulatory requirements are met for laboratory personnel training, lab records/ documentation, and overall lab record retention requirements.
• Other responsibilities as assigned by management.

• Bachelor of Science degree or equivalent, in a division of Chemistry, Biology, Biochemistry, Microbiology, or Biomedical-related discipline.
• Basic knowledge of cGMP, Quality System, and risk management principles (21CFR820, ISO 13485, ISO 14698, ISO 14971.

• Able to prepare documented investigations and reports, interpret results, and generate technical conclusions consistent with Quality risk management principles.
• Able to interpret complex results and situations with support and recognize patterns and trends in reported data. Able to effectively articulate recommendations for solutions (verbally and in writing) cross-functionally and negotiate to completion. Recognizes risk and develops contingency plans.
• Self-motivated, action-oriented, customer-focused, and skilled in building relationships, problem solving, conflict management, planning/organizing, mentoring, and analytical thinking.
• Prepares written communications with clarity and accuracy.
• Works with minimal supervision; consults management for advice on issues as needed.

Salary: £30,000 per year - plus 15% Shift Bonus

Benefits:

• Company pension
• Free parking
• AXA Private medical insurance
• Employee Referral program
• Company sick pay
• 28 days holiday plus public holidays
• Discretionary corporate bonus

• Monday to Friday 2.00pm to 10.00pm
• 37.5 Hours Per Week